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Late-stage failures and workforce impact
Neumora Therapeutics reported that its navacaprant program missed in two late-stage studies of major depressive disorder (Koastal-2 and Koastal-3), failing to achieve statistical significance on...
Psoriasis pipeline: head-to-head efficacy signal
Takeda reported Phase 3 psoriasis data for its AI-designed oral drug zasocitinib (TYK2-targeting), claiming it outperformed Bristol Myers Squibb’s Sotyktu in a head-to-head comparison. The company...
Cell therapy: move toward outpatient CAR T
Legend Biotech presented first-in-human data for LB-2501, a CD19/CD20 dual-targeting off-the-shelf CAR T, at EHA2026. Across 12 treated participants with relapsed or refractory B-cell non-Hodgkin...
Rare disease genomics: operational lift from long-read sequencing
Researchers at Radboud University Medical Center and Maastricht University reported early implementation results that long-read genome sequencing (Pacific Biosciences) improves interpretation and...
Oncology: tumor genomics plus ancestry for survival models
A European Society of Human Genetics (ESHG) presentation highlighted how combining genetic ancestry information with tumor mutation profiling can improve survival prediction in cancer. The study...
Public capital markets: biotech IPO record
Parabilis Medicines priced and began trading its IPO at the largest drug-developer offering on record in the U.S., raising $770.5 million in gross proceeds after an upsized share sale. The company...
FDA-related funding: priority review voucher cash
Rocket Pharmaceuticals said it received $180 million from the sale of a rare pediatric disease priority review voucher tied to the accelerated FDA approval of Kresladi in March. Rocket described...
Clinical neuroscience: adaptive DBS for Parkinson’s walking
UCSF researchers introduced adaptive deep brain stimulation (DBS) that changes in real time based on a person’s walking behavior, aiming to improve Parkinson’s symptom control beyond what...
Regulatory policy and access: Virginia PDAB veto
Patient advocates and industry groups praised Virginia Gov. Abigail Spanberger’s veto of Prescription Drug Affordability Board (PDAB) legislation (HB 483 and SB 271). Advocates argued that similar...
Regulatory fast-track and high-value dealmaking
Rocket Pharmaceuticals monetized a rare regulatory asset, selling an FDA pediatric disease priority review voucher tied to the accelerated approval for Kresladi in March. The company disclosed it...
Late-stage psoriasis readout for an AI-designed oral drug
Takeda reported head-to-head clinical results showing its AI-designed once-daily psoriasis pill, zasocitinib, outperformed Bristol Myers Squibb’s Sotyktu in a Phase 3 trial. In company-reported...
Outpatient, off-the-shelf CAR T data at EHA
Legend Biotech USA presented early clinical evidence for LB-2501, an off-the-shelf CD19/CD20 dual-targeting CAR T cell program, aiming to enable outpatient use. At EHA2026, investigators reported...
Ebola vaccine development accelerated for a specific species
Moderna and CEPI moved an investigational mRNA vaccine program forward for Bundibugyo virus, a rarer Ebola species driving the ongoing outbreak in the Democratic Republic of the Congo and Uganda....
Therapeutic manufacturing and translational execution guidance
A new industry-focused piece lays out decision-making steps for accelerating the lab-to-clinic transition when moving an injectable molecule into humans. The guidance centers on how drug owners...
Biotech IPOs break records again
Parabilis Medicines set a new U.S. biotech IPO record after pricing a $770.5 million offering and debuting on Nasdaq. The company raised $670 million gross proceeds with an upsized share count and...
Series B funds mid-stage depression programs
HMNC Brain Health raised $50 million in a Series B to advance two psychiatry programs into mid-stage clinical studies. Medice, a family-owned German drugmaker, led the round with additional...
New CAR T-like platform direction: adaptive, walk-in-place DBS for Parkinson’s
Researchers at UCSF reported a deep brain stimulation approach for Parkinson’s disease that adapts in real time to a patient’s walking behavior. The team described the system as tailoring...
Rare pediatric disease priority pathway monetized and pipeline financed
Rocket Pharmaceuticals’ pediatric priority review voucher sale ties regulatory acceleration to cash runway for later-stage gene therapy development. The report links the $180 million non-dilutive...
Diagnostic workflow improvement: long-read sequencing in rare diseases
A Netherlands implementation study presented at ESHG reported that long-read genome sequencing, using PacBio technology, improves interpretation and reduces the need for follow-up...
Phase 3 psoriasis results for Takeda’s AI-designed TYK2 inhibitor
Takeda reported head-to-head Phase 3 data showing its AI-designed oral psoriasis drug, zasocitinib, achieved total skin clearance in more than 35% of patients at week 16. In the company’s...